DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicants
This action is in response to the amendments and remarks filed on 08/14/2026.
Claims 1, 4-5, 8, 11, 13-17, 19-22, 26, and 85 are pending.
Corrective Actions by Applicant
Claims 1 and 26 have been amended.
Claim 10 has been canceled.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 08/14/2026 has been fully considered by the examiner.
Response to Arguments
The examiner has fully considered Applicant’s presented arguments.
On page 8 of the remarks, Applicant argues that the amendments to the claims overcome the objections to claims 1, 4-5, 8, 10-11, 13-17, 19-22, 26, and 85. This is persuasive, based on the removal of the eye height option from independent claims 1 and 26. All claim objections have thus been withdrawn.
On pages 8-14 of the remarks, Applicant argues that all claims as amended are eligible under 35 U.S.C. 101.
The examiner still argues that the majority of the steps of claims 1 and 26 (i.e., steps c-d and f-j of the original analysis) are observations, measurements, and determinations that can be practically performed in the human mind, as well as by a computer. For example, a human, such as a medical professional knowledgeable of respiratory masks, can mentally observe an image of a patient, identify and measure a reference facial feature, such as eye width, and use the known eye width to determine a scaling factor. The human can then mentally apply this scaling factor to another facial feature in the image to determine the real-world measurement of said feature and use this measurement to select a proper mask for the patient. The mental process grouping also allows the human to use pen and paper as a physical aid, such as for writing down the measurements and performing the scaling calculations in the present case.
However, the examiner agrees with Applicant’s arguments on page 9 in particular, regarding how the additional elements do integrate into a practical application.
For example, the additional element (step b) of receiving images of a patient reflects the remote, image-based mask selection environment discussed in paragraphs 0090-0094, as otherwise an in-person mask fitting would not require image analysis. These paragraphs also describe the challenges of accurate remote mask selection, such as relying on patient knowledge and/or inaccurate measurements.
The other additional element (step e) of allocating a predefined dimension to the [eye width] measurement reflects the specifications’ discussion of eye width being a consistent fiducial distance measurement across males, females, and ethnicities (see paragraphs 0097-0103).
Finally, as Applicant argues on page 10, the newly-added step specifies that the measurement of facial features requires measuring pixel distances in the image; this positively connects the scaling factor obtained from the eye width allocation to the specific unit measurements of the image. The examiner also argues that it not practically mentally performable for a medical professional to manually count out pixels of an image with high-enough resolution to facilitate accurate mask selection.
Thus, the claims integrate the mental processes into a practical application at Step 2A Prong Two, and all 101 rejections have been withdrawn.
On pages 15-16 of the remarks, Applicant argues that Khadem fails to remedy the deficiencies of Morrell and lacks motivation to combine. The examiner notes that Khadem is only relied upon for measuring eye width, not using eye width as a scaling factor. Morrell already uses scaling factors for iris width measurements, and the rejection is based on the combined teachings of these references. However, the examiner agrees with Applicant’s argument that Khadem fails to provide motivation for using eye width specifically, i.e. motivation to replace morrell’s iris width with an eye width measurement instead. Thus, all previous 35 U.S.C. 103 rejections are withdrawn. However, the claim amendments necessitate new 103 rejections presented below, using the newly-found reference He.
On page 17 of the remarks, Applicant argues that the proposed combination of Khadem with Morrell would change Morrell’s principle of operation.
The examiner notes that this argument was in regards to combining Khadem with Morrell, but this argument would apply to any reference teaching to replace Morrell’s iris width with eye width, including the new reference He.
The examiner argues that, while Applicant is correct in that replacing Morell’s iris width with eye width would require image recognition of different features, doing so does not rise to the level of changing Morrell’s principle of operation. In combination with He, Morrell would still perform the same goal of using a reference distance to measure facial features for mask selection, by analyzing the same facial images, just using a slightly different measurement of the eyes. Such an implementation detail does not require a substantial reconstruction or redesign as exampled by MPEP 2143.01.VI.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-5, 8, 11, 13-14, 16, 20, 22, 26, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Morrell et al. (U.S. Publ. US-2023/0103129-A1) in view of He et al. (U.S. Publ. US-2022/0414364-A1).
Regarding claim 1, Morrell discloses a method for selecting a mask for a patient for use with a respiratory therapy device (see figures 4-5 and 11), the mask suitable to deliver respiratory therapy to the patient (see paragraphs 0001-0004), comprising the steps of:
receiving data representing at least one digital image of a face of a patient (see paragraph 0075, where a stream or sequence of images are received);
identifying a predefined reference facial feature appearing in the at least one digital image, the predefined reference facial feature being an eye of the patient (see figure 4, step 407, 410, 413 and paragraph 0093, where coordinates of eye landmarks are identified);
determining a measurement for the eye of the patient within the at least one digital image (see figure 5, steps 413, 320 and paragraphs 0100-0101, where the eye coordinates are used to measure the horizontal or vertical iris diameters of the eyes),
allocating a predefined dimension to the measurement, and determining a scaling factor for the at least one digital image, the scaling factor being a ratio between the measurement and the predefined dimension (see figure 5, step 507 and paragraphs 0100-0101, where a scaling factor is determined as a ratio between the pixel diameter of the iris and a predetermined fixed value/predefined dimension representing a known physical measurement, such as millimeters);
identifying a further facial feature in the at least one digital image (see figure 5, step 510, 515 and paragraphs 0102-0103, where facial landmarks for the nose and other facial features are obtained);
determining a measurement of the further facial feature in the at least one digital image; and calculating a calculated dimension of the further facial feature using the scaling factor and the measurement of the further facial feature (see figure 5, steps 512, 517, 520 and paragraphs 0101-0105, where the scaling factor is applied to pixel measurements of nose width, nose depth, and face height to convert them to physical measurements);
and, comparing the calculated dimension of the further facial feature with mask sizing data associated with patient masks and selecting a mask for the patient in dependence on the comparison (see figure 5, step 520; figure 11, step 1130 and paragraphs 0111, 0175-0176, and 0201, where the determined facial measurements can be used to select a mask for the patient, such as by comparing to preset dimensions for pre-designed masks);
wherein the step of determining a measurement of a facial feature is performed by calculating a number of pixels of the at least one digital image between at least two facial landmarks in the at least one digital image associated with the facial feature (see paragraph 0049, where, for example, the facial height is measured as the distance between the sellion and supramenton).
Morrell fails to disclose determining a measurement for the eye of the patient within the at least one digital image, wherein the measurement for the eye of the patient is an eye height (emphasis added via underline). In other words, the only deficiency of Morrell regarding claim 1 is that Morrell uses iris width as the reference distance for calculating the scaling factor, instead of eye width.
Pertaining to the same field of endeavor, He discloses determining a measurement for the eye of the patient within the at least one digital image, wherein the measurement for the eye of the patient is an eye width (see paragraphs 0030-0032, where measurements of facial feature dimensions are performed for biometric facial recognition; paragraph 0030 specifies that the width of an eye can be used as a reference value to measure other facial features, i.e. a mouth can be measured as 1.328 left-eye-widths across; this paragraph also specifies that these measurements can be converted to other units, such as pixels or millimeters; paragraph 0031 specifies that either eye width or iris width can be used).
Morrell and He are considered analogous art, as they are both directed to facial image analysis for determining facial proportions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of He into Morrell by replacing Morrell's iris width with eye width because both are high-contrast features with relatively unchanging dimensions (see He paragraphs 0030-0031). He discloses both iris and eye width as desirable alternatives for facial feature measurement, which is a goal He shares with Morrell (see MPEP 2143.01.I).
Regarding claim 4, Morrell in view of He discloses wherein the step of identifying an eye of the patient in the at least one digital image is performed by identifying at least two predefined facial landmarks, being anthropometric features of the face of the patient, in the at least one digital image associated with the eye (see Morrell paragraph 0093, where landmarks can include the top/bottom of each eye, inner/outer corners of each eye, and edges of the pupil/iris of each eye).
Regarding claim 5, Morrell in view of He discloses wherein the at least two predefined facial landmarks in the at least one digital image are corners of the eye or a medial canthus and a lateral canthus (see Morrell paragraph 0093, where landmarks can include the top/bottom of each eye, inner/outer corners of each eye, and edges of the pupil/iris of each eye).
Regarding claim 8, Morrell in view of He discloses wherein the further facial feature is identified by identifying at least two facial landmarks associated with the further facial feature (see Morrell paragraphs 0049, 0062, and 0095, where identification of the nose, mouth, and face height involve multiple landmarks, such as the sellion, supramention, nose tip, bottom of the chin, etc.).
Regarding claim 11, Morrell in view of He discloses wherein the step of determining the measurement for the eye of the patient within the at least one digital image is performed by identifying two eyes of the patient within the at least one digital image and calculating a measurement for each eye and calculating an average measurement for the two eyes (see Morrell paragraph 0101, where both the left and right eyes can be identified, their iris diameters measured, and then the two values are averaged to determine the scaling factor).
Regarding claim 13, Morrell in view of He discloses determining at least one attribute of the at least one digital image; comparing the at least one attribute with predefined attribute criteria; and determining whether the at least one attribute meets the predefined attribute criteria (see Morrell see figure 4, steps 330, 405 and paragraphs 0088-0091, where each image is analyzed to determine if they depict desired facial angles, as well as the absence of glasses on the patient's face);
wherein at least one of the steps of: identifying an eye of the patient; determining a measurement for the eye of the patient; allocating a predefined dimension to the measurement; determining a scaling factor; identifying a further facial feature; determining a measurement of the further facial feature; calculating a calculated dimension of the further facial feature; and selecting a mask for the patient is performed in dependence on the at least one attribute meeting the predefined attribute criteria (Morrell paragraphs 0031 and 0091 specify that only images that pass the above criteria are further processed by the method).
Regarding claim 14, Morrell in view of He discloses wherein the at least one attribute comprises at least one of: an angle of the face of the patient within the at least one digital image, the angle being at least one of a pitch angle, a yaw angle or a roll angle; a focal length of the at least one digital image; depth of the face of the patient in the at least one digital image; and at least one predefined landmark being identified in the at least one digital image (see Morrell paragraphs 0031 and 0080, where the criteria can include a facial tilt in any direction within a specified angle threshold).
Regarding claim 16, Morrell in view of He discloses providing feedback relating to whether the at least one attribute meets the predefined attribute criteria (see Morrell paragraphs 0054 and 0059).
Regarding claim 20, Morrell in view of He discloses determining a determined mask category for the patient (see Morrell paragraph 0201).
Regarding claim 22, Morrell in view of He discloses wherein the further facial feature is selected from a plurality of facial features in dependence on the determined mask category (see Morrell paragraph 0034, where the particular facial measurements that are determined and used can vary depending on the particular task or mask type being evaluated),
wherein different mask categories have different relationships between mask sizing data and dimensions of facial features, and wherein the mask sizing data for the determined mask category includes data relating to the selected further facial feature of the plurality of facial features (see Morrell paragraph 0201, where each pre-designed mask is associated with a set of facial measurements, such as facial height and nose depth).
Regarding claim 26, Morrell discloses a system for selecting a mask for a patient for use with a respiratory therapy device (see figure 14), the mask suitable to deliver respiratory therapy to the patient (see paragraphs 0001-0004), the system comprising: a processor configured to (see figure 14, CPU 1405).
Morrell also discloses a memory for storing mask sizing data associated with patient masks (see figure 14, memory 1410).
The remainder of the claim recites that the processor performs steps identical to those of claim 1. Therefore, Morrell in view of He discloses claim 26 as applied to claim 1 above.
Regarding claim 85, Morrell in view of He discloses wherein the system comprises a mobile communications device (see Morrell paragraph 0038), the mobile communications device further comprising: an image capture device for capturing digital image data (see Morrell paragraph 0051); and a user interface to display data related to the at least one selected mask (see Morrell paragraph 0055).
Claims 15, 17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Morrell et al. (U.S. Publ. US-2023/0103129-A1) in view of He et al. (U.S. Publ. US-2022/0414364-A1), and further in view of Fu et al. (U.S. Publ. US-2018/0117272-A1).
Regarding claim 15, Morrell in view of He fails to disclose the new limitations of claim 15.
Pertaining to the same field of endeavor, Fu discloses wherein the at least one attribute is a pitch angle, the predefined attribute criteria being an angle between 0 to +-6 degrees with respect to a plane of the at least one digital image (see paragraph 0161, where the tilt angle can be a tilt in any direction within +/- 1, 3, or 5 degrees).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and He because doing so increases measurement accuracy (see Fu paragraph 0161).
Regarding claim 17, Morrell in view of He fails to disclose the new limitations of claim 17.
Pertaining to the same field of endeavor, Fu discloses wherein the step of calculating the calculated dimension of the further facial feature is performed for multiple images of the at least one digital image to produce multiple calculated dimensions (see figure 6C, steps 610-670 and paragraph 0171, where the steps can be repeated for a plurality of captured images),
the method comprising the further step of calculating an average dimension of the further facial feature across at least a predetermined number of the multiple images (see figure 6C, step 680 and paragraph 0172);
and using the average dimension to compare with the mask sizing data (see figure 6D, steps 730, 732 and paragraphs 0176-0177, where the final facial feature measurements are compared to data records of patient interfaces/masks to select a mask of best fit).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and He because averaging the measurements across multiple images increases accuracy (see Fu paragraph 0163).
Regarding claim 19, Morrell in view of He fails to disclose the new limitations of claim 19.
Pertaining to the same field of endeavor, Fu discloses determining at least one attribute of the multiple images; comparing the at least one attribute with predefined attribute criteria; and determining whether the at least one attribute meets the predefined attribute criteria (see figure 6A, step 440 and paragraph 0160, where the image is analyzed to determine if the reference feature is fully depicted; see figure 6A, step 450 and paragraph 0161, where the tilt of the device and thus of the image are obtained, and compared to a threshold value to determine if the tilt is acceptable);
wherein the average dimension is calculated across the multiple images which meet the predefined attribute criteria (see figures 6A-6D and paragraph 0162, where all subsequent steps to those of figure 6A are only performed if the alignment parameters and any other required conditions are satisfied, thus only images that satisfy the criteria are used for the averaging process).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and He because averaging the measurements across multiple images increases accuracy (see Fu paragraph 0163).
Regarding claim 21, Morrell in view of He fails to disclose the new limitations of claim 21.
Pertaining to the same field of endeavor, Fu discloses presenting at least one patient question to the patient; receiving at least one patient response to the at least one patient question; and determining a determined mask category for the patient in dependence on the at least one patient response (see paragraph 0149, where the patient can be prompted with a set of questions, where the responses can be used to determine the patient interface/mask type).
Morrell and Fu are considered analogous art, as they are both directed to facial image analysis using reference distances for mask selection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Fu into Morrell and He because doing so allows for further mask determination based on patient input (see Fu paragraph 0149).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS JOHN HELCO whose telephone number is (703)756-5539. The examiner can normally be reached on Monday-Friday from 9:00 AM to 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella, can be reached at telephone number 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS JOHN HELCO/Examiner, Art Unit 2667 /MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667
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